Costa Rica Ministry of Health Overview

The Costa Rican Ministry of Health is responsible for regulating the healthcare industry in Costa Rica. It also acts as the regulatory agency for food, drugs, chemicals and medical devices, ensuring these products are up to standards.

The legal framework is based on Law No. 5395 (the General Health Law), Decree No. 34482-S (Regulation for the registration classification, control and imports of biomedical material and equipment), and by Act No. 32780-S (establishing the fees for registration of biomedical material and equipment).

Major Regulations

Some of the most important regulations for medical devices in Costa Rica are:

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